FDA.reportPublic FDA data

Neodent

Primary DI
07899878066989
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
106.281
Catalog number
106.281
Device description
NEODENT SCANHEAL D3.5X0.8/1.5/2.5
Published
2026-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899878066989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899878066989078998780669897899878066989

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00keep dry

Contacts#

Phone, Email table
PhoneEmail
+1(855)412-8883customerservice.us@instradent.com

Regulatory Flags#

DUNS number
906713888
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899878068143Neodent125.226125.2262026-10-09
07899878068150Neodent103.751103.7512026-10-09
07899878068167Neodent103.752103.7522026-10-09
07899878068174Neodent103.753103.7532026-10-09
07899878068181Neodent118.413118.4132026-09-25
07899878068198Neodent118.414118.4142026-09-25
07899878068211Neodent138.196138.1962026-09-25
07899878068228Neodent138.197138.1972026-09-25
07899878068235Neodent116.309116.3092026-09-25
07899878068242Neodent116.308116.3082026-09-25
07899878068259Neodent118.415118.4152026-09-25
07899878068266Neodent104.075104.0752026-09-25
07899878068273Neodent104.078104.0782026-09-25
07899878068280Neodent104.076104.0762026-09-25
07899878068297Neodent104.077104.0772026-09-25
07899878066996Neodent106.282106.2822026-07-03
07899878067009Neodent106.283106.2832026-07-03
07899878067016Neodent106.284106.2842026-07-03
07899878067023Neodent106.285106.2852026-07-03
07899878067030Neodent106.286106.2862026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968514098plant Implant System8dent Inc.NHA2026-10-23
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088000968515468plant Implant System8dent Inc.NHA2026-10-23
088000968582178plant Implant System8dent Inc.NHA2026-10-23
088000968582248plant Implant System8dent Inc.NHA2026-10-23
088000968582318plant Implant System8dent Inc.NHA2026-10-23
088000968585528plant Implant System8dent Inc.NHA2026-10-23
088000968587058plant Implant System8dent Inc.NHA2026-10-23
088000968599008plant Implant System8dent Inc.NHA2026-10-23
088000968600298plant Implant System8dent Inc.NHA2026-10-23
088000968600508plant Implant System8dent Inc.NHA2026-10-23
088000968601808plant Implant System8dent Inc.NHA2026-10-23
088000968602038plant Implant System8dent Inc.NHA2026-10-23
088000968608768plant Implant System8dent Inc.NHA2026-10-23
088000968611948plant Implant System8dent Inc.NHA2026-10-23
088000968617368plant Implant System8dent Inc.NHA2026-10-23
088000968617438plant Implant System8dent Inc.NHA2026-10-23
088000968618288plant Implant System8dent Inc.NHA2026-10-23
088000968618358plant Implant System8dent Inc.NHA2026-10-23
088000968620098plant Implant System8dent Inc.NHA2026-10-23
088000968620168plant Implant System8dent Inc.NHA2026-10-23
088000968620238plant Implant System8dent Inc.NHA2026-10-23
088000968622698plant Implant System8dent Inc.NHA2026-10-23
088000968622768plant Implant System8dent Inc.NHA2026-10-23
088000968650248plant Implant System8dent Inc.NHA2026-10-23
088000968650798plant Implant System8dent Inc.NHA2026-10-23
088000968688418plant Implant System8dent Inc.NHA2026-10-23
088000968688588plant Implant System8dent Inc.NHA2026-10-23
088000968788338plant Implant System8dent Inc.NHA2026-10-23